Creating a Global CMC Dossier to Achieve Operational Readiness, Upcoming Webinar Hosted by Xtalks

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In this free webinar, learn about the possibilities of harmonising the CMC sections of a global dossier. Attendees will learn about potential regulatory reliance strategies for a streamlined approval and how to navigate post approval CMC changes through regional differences.

It is not only the content of the CMC dossier that will affect the outcome but also the route of registration chosen.

This webinar presents potential steps to be taken in compiling a truly global CMC dossier. The webinar will discuss how CMC authors and regulatory leaders can best manage the ever-changing regulatory landscape.

The process of developing a new formulation through regulatory approval to achieve operational readiness, is a complicated and multi-dimensional process. The chemistry, manufacturing and controls alone require specialised knowledge and consideration of regional differences. The webinar discusses the key strategies for developing a robust CMC dossier and outlines potential routes to avoid common deficiencies that can lead to a longer regulatory review cycle.

It is not only the content of the CMC dossier that will affect the outcome but also the route of registration chosen. The speaker will discuss some of the options available to Marketing Authorisation Holders for a multi-authority review via regulatory reliance pathways.

A major area of divergence in CMC requirements is often seen with post approval requirements. The speaker will tackle the subject of regulatory options post product approval and consider if it is possible to maintain a harmonised global CMC dossier. Diverging regional requirements as specified by local regulatory authorities result in unaligned implementation times, differing regulatory packages and can lead to difficulties in harmonising changes execution.

Register for this webinar to learn about the possibilities of harmonising the CMC sections of a global dossier. Learn about potential regulatory reliance strategies for a streamlined approval and how to navigate post approval CMC changes through regional differences.

Join Rachel Harte, Associate Director Regulatory Affairs, CAI, for the live webinar on Monday, November 28, 2022, at 10am EST (4pm CET/EU-Central).

For more information, or to register for this event, visit Creating a Global CMC Dossier to Achieve Operational Readiness.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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Vera Kovacevic
Xtalks
+1 (416) 977-6555 x371
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